ICLE Comments on Section 232 Investigation into PPE, Medical Consumables, and Medical Equipment
I. Introduction
The International Center for Law & Economics (ICLE) appreciates this opportunity to comment on the Bureau of Industry and Security’s investigation of the national-security implications of imports of personal protective equipment (PPE), medical consumables, and medical equipment. ICLE is a nonprofit research center that applies economic analysis to questions of law and regulation.
We oppose the application of Section 232 tariffs to medical devices and related products. The United States leads the world in medical-technology innovation and manufacturing, supported by open, rules-based trade with trusted allies. Imports of devices and components complement, rather than displace, U.S. production. Moreover, they are essential to maintain an efficient, resilient, and globally competitive health-care system.
Tariffs would raise costs for hospitals and patients, suppress investment and R&D, and undermine the very innovation that underpins U.S. health-security preparedness. Consistent with Section 232’s statutory purpose, U.S. policy should reinforce the strength of allied supply chains and maintain predictable, cooperative trade relationships that support—not impair—the nation’s medical-technology base.
II. Economic and Public-Health Impacts of Tariffs
Open and competitive trade is the foundation of economic prosperity, especially in innovation-driven sectors like medical technology. When markets are open, firms face competitive pressure to become more efficient, adopt new technologies, and invest in R&D. A broad literature confirms that exposure to global markets drives productivity growth, facilitates technology transfer, and supports sustained U.S. global leadership: the United States controls roughly 40% of the medical-technology (“medtech”) market, while export volumes exceed $141 billion and industry reinvestment in product innovation remains high.[1]
The proposed application of Section 232 tariffs would reverse this dynamic, imposing new costs and instability throughout the medical-technology ecosystem. Modern trade theory emphasizes that comparative advantage evolves dynamically.[2] Access to international markets reshapes domestic capabilities by rewarding sectors that innovate and scale globally. This dynamic interplay between openness and innovation explains why U.S. medtech firms dominate such advanced product segments as imaging, diagnostics, and surgical robotics.
Conversely, barriers like tariffs or quotas impede this evolution, isolating firms from global knowledge flows and eroding long-term competitiveness. Maintaining open, rules-based trade with trusted partners thus strengthens—not threatens—U.S. economic security by reinforcing innovation, efficiency, and resilience in critical health-related industries.
Moreover, imposing tariffs on imports of medical devices, consumables, or related components under Section 232 would increase costs throughout the U.S. health-care system, slow adoption of advanced technologies, and weaken—rather than strengthen—national resilience. Because U.S. health providers operate under fixed reimbursement schedules, any increase in device costs directly translates into higher expenditures for hospitals, insurers, and Medicare, ultimately reducing patient access to life-saving technologies.
A. Tariffs Would Raise Input Costs for Hospitals and Health Systems
Hospitals and health systems already face persistent financial pressure due to inflation, labor shortages, and static Medicare-reimbursement rates. Tariffs would compound these pressures by increasing the cost of imported components and finished products that are integral to medical care. A 2024 analysis found that 82% of health-system executives expected tariff-related import expenses to raise hospital costs by about 15% within six months.[3] Likewise, tariffs on critical supplies are expected to increase costs and reduce availability of key products for hospitals.[4] These higher input prices are not absorbed by manufacturers alone; they are passed through the supply chain and ultimately borne by hospitals, private insurers, and federal programs like Medicare and Medicaid.
During prior rounds of Section 301 tariffs on Chinese medical imports, manufacturers and distributors in the medical-device sector reported cost pressures on various device components and subassemblies—such as electronics, sensors, housings, and tubing—especially for diagnostic, monitoring, and surgical devices.[5] This experience illustrates that trade restrictions intended to promote domestic production often have the opposite effect in highly integrated industries—eroding competitiveness and diminishing capacity for innovation.
B. Tariffs Would Raise Consumer Prices and Delay Adoption of Advanced Medical Technologies
Medical devices are capital-intensive goods with long procurement cycles and complex regulatory-approval requirements. When hospitals anticipate higher import prices or uncertain supply, they may postpone or cancel equipment upgrades. Tariffs on medical products would likely further strain an already fragile health-care supply chain, driving up costs and reducing the availability of essential medical devices and equipment.[6] Similarly, medtech manufacturers anticipate a combined tariff impact of more than $2 billion across 2024-2025, forcing many firms to reduce production and defer new-product launches.[7] As device upgrades are delayed, hospitals must continue using older, less-efficient technologies—directly undermining the goal of a modern and resilient health-care infrastructure.
Moreover, while a few multinational firms maintain relatively high returns, the medical-device sector actually operates on narrow effective margins, once research, compliance, and capital costs are included. Large device companies typically have profit margins of 20-30%.[8] Yet industry data suggest that the medical equipment and supplies sector on the whole now reports net margins in the upper single digits, with operating margins near 10%.[9] Recent financial benchmarking indicates that smaller and mid-sized medical-device manufacturers—firms responsible for much of the industry’s innovation—operate with earnings before interest and taxes (EBIT) of roughly 4.6% of their revenues, reflecting the sector’s tight margins relative to larger diversified medtech companies.[10] When margins are this thin, tariff costs cannot be easily absorbed; they are inevitably passed through, in large part, to hospitals and consumers in the form of higher prices.
Reduced profitability and policy uncertainty also discourage R&D investment. Industry analysis illustrates that medtech profitability has declined globally in recent years, with average operating income falling by roughly three percentage points, as inflation, supply-chain disruptions, and regulatory costs have all increased.[11] Additional tariff-driven cost increases would intensify this compression, leaving fewer resources for R&D and compliance.
And while medtech firms often enjoy healthy gross margins, those margins are critical to funding ongoing innovation. When those margins erode, firms lose the flexibility to reinvest in R&D, slowing the pace of new-product development.[12] Tariffs will shrink both the gross margins and the net margins, driving further retrenchment and depressing institutional capacity to invest in R&D.
The combined effect of higher import prices, reduced investment, and delayed innovation would therefore be fewer new medical technologies entering the U.S. market and slower replacement of aging equipment. In the long term, these consequences would erode the resilience of the U.S. health-care system—the very objective that these Section 232 investigations seek to secure.
C. Trade-Policy Uncertainty and Investment in Medical Technology
Even before tariffs take effect, the uncertainty surrounding their potential imposition can suppress investment and innovation in the medical-technology sector. Economists have long observed that volatility in trade policy leads firms to postpone or cancel capital expenditures and R&D, a dynamic known as the “real options” effect. When future input costs or market-access rules are unclear, it becomes rational for companies to delay irreversible investments until policy direction stabilizes. The cumulative effect across the industry is lower aggregate investment, slower entry into new markets, and diminished innovation.[13]
Empirical studies of the 2018–2019 trade-tension period found that a one-standard-deviation rise in trade-policy uncertainty reduced U.S. manufacturing investment by roughly 1–2% over the following year, independent of what actual tariff levels were imposed.[14] For innovation-intensive industries like medtech—where R&D costs typically take up 8% of annual revenues[15]—policy instability can translate quickly into deferred product development and delayed regulatory submissions. Firms facing uncertainty about tariff coverage, reimbursement effects, or retaliatory measures have strong incentives to redirect resources toward short-term operations, rather than long-term innovation.
Stable and predictable trade rules therefore constitute a precondition for maintaining U.S. technological leadership in medical devices. A tariff-driven environment characterized by periodic investigations and changing duty rates not only raises costs directly, but also magnifies uncertainty, depressing forward-looking investment across the supply chain. In this sense, trade-policy volatility functions as a hidden tax on innovation. A consistent, rules-based approach to international medical-device trade, anchored in transparency and allied cooperation, would better support the long-term competitiveness and national-security resilience of the U.S. medtech industry.
D. Tariffs on PPE Are an Inappropriate Economic Tool to Promote Reshoring
Importantly, Section 232 authority was designed to address genuine national-security threats from adversarial sources, not to penalize allied trade. Historically, successful 232 actions have targeted steel, aluminum, or critical minerals dominated by non-allied producers.[16] Applying this national-security tool to medical devices imported chiefly from NATO and USMCA partners would be inconsistent with both statutory intent and economic logic.[17] As the Bureau of Industry and Security has noted, the statute’s purpose is to mitigate “whether the importation of the article in question is in such quantities or under such circumstances as to threaten to impair the national security,” not to disrupt allied cooperation essential to public health.[18]
Further, medical-device manufacturing is inherently capital intensive and heavily regulated by the U.S. Food and Drugs Administration (FDA). Under 21 C.F.R. Part 820, manufacturers must validate every production line and supplier, with significant documentation and preapproval requirements for any process change.[19]
Although a tariff shock might be intended to spur reshoring, firms must in practice incur significant sunk costs and time to requalify suppliers and production processes. In the medical-device sector, supplier requalification itself often takes months, and includes mandatory audits, capability studies, quality-agreement updates, and validation under regulatory frameworks like 21 C.F.R. § 820.[20] Because many changes may require full validation of process and materials, the short-term shift in capacity is highly constrained and may lead to disruptions or shortages before any new domestic capacity becomes viable.
In short, Section 232 tariffs on medical devices and PPE would misidentify the source of risk. They would penalize integrated trade with close allies, undermine established regulatory and manufacturing networks, and inflict economic harm on precisely the industries that anchor U.S. health-security resilience.
III. The U.S. Medical Technology Industry: A Global Leader
Given the foregoing description of the economics of the medtech industry, it is worth asking why this sector—long a cornerstone of U.S. innovation and export strength—should be viewed as a national-security vulnerability at all. The United States is the undisputed global leader in medical-technology innovation and manufacturing. Indeed, U.S. companies account for roughly 40% of worldwide medical-device production, by far the largest share of any country.[21]
The medtech sector is defined by high-value, research-intensive manufacturing. The industry consistently reinvests around 7–8% of revenues into R&D, ranking among the highest R&D intensities in manufacturing.[22] This robust innovation ecosystem—fueled by leading research universities, deep venture-capital markets, and strong intellectual-property protections—drives continual advances in imaging equipment, in-vitro diagnostics, surgical robotics, and implantable devices. For example, U.S. firms are at the forefront of MRI and CT imaging technology, next-generation glucose monitors and diagnostic assays, robotic-assisted surgical systems, and artificial joints and stents, among many other cutting-edge products.[23]
The industry’s emphasis on innovation not only saves lives but also supports a high-skill domestic workforce: approximately 500,000 workers are employed directly in the U.S. medical-device-manufacturing industry, with total direct and indirect employment approaching 2 million.[24]
U.S. medtech firms are also vigorous exporters. The United States exported more than $100 billion in medical devices and related equipment in 2023.[25] Even in key product categories where global competition is intense, American firms excel. In earlier years, the United States achieved net export surpluses in high-value device categories such as diagnostic imaging and orthopedics. [26] Although more recent trade data show changes in the balance, the United States remains a leading global exporter in those segments.[27] These high-end devices—often produced by U.S. companies at home or in close trade-partner countries—compete on quality and innovation, rather than low cost.
In sum, the U.S. medtech industry’s global leadership is built on innovation, skilled employment, and export success. These factors underscore that America’s medical-device-manufacturing base is strong and globally competitive, a foundation for national health security that open trade further reinforces.
A. Allied Trade Relationships and Balanced Flows
The U.S. medical technology industry is deeply integrated into reciprocal trade relationships with allied economies, resulting in balanced flows of devices and components. America’s major trading partners for medical devices are not adversaries, but close allies: Europe (especially Germany, Ireland, and the Netherlands), Canada, Mexico, Japan, South Korea, and Singapore are both among the top sources of U.S. medtech imports and major destinations for U.S. exports.
In 2018, for example, the United States exported more than $20 billion in medical devices to the EU, which has historically accounted for nearly 40% of U.S. device exports.[28] Import data show that the European Union is also an important supplier of U.S. medical instruments. In 2023, it contributed roughly $11.5 billion of $19.5 billion in U.S. imports in that device category (roughly 59%).[29]
Meanwhile, North American partners—especially Canada and Mexico—play significant roles as regional suppliers and exporters in complementary device segments.[30] U.S.–Mexico trade in medical devices is largely balanced and complementary. In recent years, Mexico has been the leading supplier of U.S. medical-device imports, accounting for roughly 17% of total import value—mainly lower-technology products such as disposables and surgical instruments produced through cross-border manufacturing.[31]
Canada is also both a significant market and supplier in U.S. medical-device trade. Exports of medical equipment, supplies, and control instruments from Canada to the United States exceeded $6.8 billion in 2024.[32] Meanwhile, in 2024, Canada’s medical-device imports from the United States were C$5.9 billion, representing about 42% of Canada’s total medtech imports.[33]
In Asia, Japan and South Korea both purchase high-value U.S. devices (for example, Japanese hospitals import American orthopedic implants and diagnostic instruments), even as companies in those countries supply the United States with specialized components like optical lenses and semiconductor parts for medical equipment.[34]
These trade relationships are characterized by a two-way flow of goods: U.S. companies export complex finished devices and receive in return a range of inputs, subassemblies, and some finished products from allied nations. Importantly, imports from China constitute only a relatively small fraction of U.S. medtech imports (roughly 10% in recent years) and that share has been declining as U.S. sourcing diversifies toward allied suppliers.[35]
The evidence suggests a supply-chain strategy centered on trusted partners. The reciprocity and balance in these trade flows demonstrate that imports are largely coming from friends, and U.S. firms are succeeding in selling globally. Far from one-sided dependence, U.S. medtech trade with allies strengthens all parties.
B. Imports’ Role in Meeting U.S. Health-Care Demand
The COVID-19 pandemic offered a stark illustration of the importance of global supply networks in meeting surges in health-care demand. In normal times, imports fill critical gaps in the U.S. health system’s needs for medical devices and supplies, especially for specialized or lower-volume products that are not efficient to manufacture domestically at scale.
During the height of the pandemic, the United States leveraged imports from allies to rapidly scale up life-saving equipment. A prominent example was the surge in ventilator production in 2020: even as American manufacturers like General Motors and ventilator companies retooled to assemble ventilators domestically, they depended on imported inputs (valves, sensors, oxygen concentrators, etc.) from partner countries to boost output. According to contemporary analyses, the only feasible way to meet the unprecedented 500–1,000% increase in ventilator demand was to “supercharge ventilator makers’ global production capacities” by pooling resources across borders, rather than attempting total self-reliance.[36]
For example, Medtronic’s Ireland-based ventilator manufacturing facility reportedly ramped up production, reallocating staff and expanding shift coverage to supply global demand.[37] More broadly, European manufacturers took coordinated steps to bolster ventilator-component supply chains across countries.[38] Similarly, COVID-19 diagnostic test kits were produced through transnational cooperation, with U.S. labs relying on reagents and chemicals from allies (and vice versa) to scale up testing quickly.[39]
In short, imports function as both a safety valve and a source of resilience for U.S. health care; they ensure that American patients and doctors have timely access to every medical tool needed, especially when domestic production alone cannot immediately meet a spike in demand.
C. Resilience Through Diversification, Not Isolation
Policymakers increasingly recognize that supply-chain resilience in medical technology comes from diversification across trusted partners, rather than from attempting an autarkic approach. Empirical research on the recent supply disruptions demonstrates that geographic concentration of production is the primary vulnerability—for instance, overreliance on a single country or region for a critical component can create a choke point—whereas maintaining “safe openness” through a broad network of suppliers reduces risk.[40] Resilient medical supply chains depend on broad, cross-border diversification with built-in redundancies that allow production to adjust rapidly in response to shocks or disruptions.[41] In the medical-device sector, both industry and government have moved to implement this lesson.
U.S. and European manufacturers are increasingly coordinating to establish redundant production capacity for critical products. For example, U.S. medtech OEMs maintain production sites abroad to enable geographic flexibility in manufacturing.[42] Some have explicitly expanded manufacturing operations in Singapore and Southeast Asia, enabling them to shift production among locations in response to demand or disruption.[43] Major medtech firms from the United States, EU, and Japan also frequently rely on one another’s components, creating inherent redundancies—if one source goes offline, alternative sources in another allied nation can fill the gap.[44]
Such collaborative redundancy is bolstered by reciprocal regulatory recognition initiatives among allies. A salient case is the Medical Device Single Audit Program (MDSAP), which pledges the FDA and regulators in Canada, Japan, Australia, and other jurisdictions to accept a single standardized quality audit of a device manufacturer.[45] Programs like MDSAP streamline compliance across countries, enabling companies to shift production or substitute suppliers rapidly across jurisdictions without regulatory delay. Likewise, international regulatory guidance—such as the International Medical Device Regulators Forum’s (IMDRF) medical-device cybersecurity framework—explicitly aims for convergence of cybersecurity principles and practices across jurisdictions to preserve device functionality and patient safety, thereby enabling mutual reliance on allied medical products in emergencies.[46]
Crucially, embracing imports from a diverse set of allied economies enhances U.S. preparedness. A strong consensus has emerged that attempting to localize entire supply chains domestically would undermine resilience by cutting off access to alternative sources. A 2024 OECD report, for example, found that shortages in critical medical goods were best addressed by maintaining multiple sourcing options across different countries—smoothing potential disruptions.[47] Diversified global supply networks tend to recover faster from shocks than isolated national chains.[48] Similarly, countries with more trade partners had fewer medical supply shortages during COVID-19, whereas those dependent on one foreign source or solely on domestic production faced greater scarcity.[49]
The medtech sector’s own experience confirms that open, allied trade is a strength. The U.S. medical technology base is robust, in large part, due to its global links. Diversified sourcing enables “a consistent response to external stressors” and prevents overreliance on any single market or supplier.[50] In short, maintaining and expanding imports from trusted allies is not a strategic liability but a strategic asset for the United States. It builds redundancy, ensures access to lifesaving technologies not made at home, and grants flexibility to manage crises. In the face of pandemics and other disruptions, a diverse allied supply chain is America’s first line of defense, whereas protectionism and concentration would only foment greater fragility.
IV. Conclusion
The U.S. medtech sector is a pillar of both economic strength and national health security. Its global leadership depends on openness, stability, and collaboration with trusted trade partners. Section 232 tariffs on medical devices or PPE would erode these advantages—raising costs, amplifying uncertainty, and diverting resources away from the research and innovation that safeguard public health.
Rather than broad trade restrictions, national-security policy should focus on targeted, evidence-based measures that address specific vulnerabilities, while preserving the benefits of allied integration. A predictable, rules-based trade environment is essential to maintain U.S. competitiveness, investment, and readiness in critical medical technologies.
Accordingly, ICLE urges the U.S. Commerce Department to reject the use of Section 232 tariffs in this proceeding and to reaffirm that open, cooperative trade among allies is an asset to U.S. security—not a threat to it.
[1] See Medical Technology Industry, U.S. Int’l Trade Admin. SelectUSA, https://www.trade.gov/selectusa-medical-technology-industry (last visited Oct. 15, 2025); see also Medical Technologies, U.S. Int’l Trade Admin., https://www.trade.gov/medical-technologies-0 (last visited Oct. 15, 2025).
[2] See infra Section III.
[3] Sunit Patel & Rupert Watson, The Impact of Tariffs on Healthcare Costs, Mercer (Apr. 10, 2025), https://www.mercer.com/en-us/insights/us-health-news/the-impact-of-tariffs-on-healthcare-costs.
[4] Tina Freese Decker, Tariff Implications for American Health Care, AHA News (May 19, 2025), https://www.aha.org/news/chairpersons-file/2025-05-19-tariff-implications-american-health-care.
[5] See, e.g., Analysis of Section 301 Tariff Impacts on Electromedical Devices, Wash. Int’l Trade Ass’n (2022), available at https://www.wita.org/wp-content/uploads/2022/08/CTA_Section-301-Tariff-Whitepaper.pdf; see also The Hidden Risks of Tariffs in Medical Device Supply Chains, Everstream Anal., https://www.everstream.ai/articles/hidden-risk-tariffs-medical-devices (last visited Oct. 16, 2025).
[6] Robert M. Orfaly, Tariffs May Strain the Fragile Healthcare Supply Chain, AAOS Now (May 29, 2025), https://www.aaos.org/aaosnow/2025/may/commentary/commentary01.
[7] Susan Kelly, Cost Cuts, Production Shifts: How MedTech Firms Are Managing Tariffs, MedTech Dive (May 22, 2025), https://www.medtechdive.com/news/medtech-Q1-earnings-tariffs-impact/748794.
[8] An Overview of the Medical Device Industry (Ch. 7), in Report to the Congress: Medicare and the Health Care Delivery System, Medicare Payment Advis. Comm’n (Jun. 2017), available at https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/reports/jun17_ch7.pdf.
[9] Medical Equipment & Supplies Industry Profitability Ratios, CSIMarket, https://csimarket.com/Industry/industry_Profitability_Ratios.php?ind=804 (last visited Oct. 15, 2025).
[10] Medical Device Manufacturing: Industry M&A Trends, Valuation, and Financial Performance, InvestmentBank.com (Jun. 22, 2025), https://investmentbank.com/insights/medical-device-industry.
[11] Global MedTech 2023 – Stem the Tide, Roland Berger (2023), available at https://content.rolandberger.com/hubfs/07_presse/Global_MedTech_2023.pdf.
[12] See id.; See also Pulse of the MedTech Industry Report 2025, EY Insights (2025), available at https://www.ey.com/content/dam/ey-unified-site/ey-com/en-gl/industries/life-sciences/documents/ey-gl-medtech-pulse-report-09-2025.pdf.
[13] See, generally, Dario Caldara et al., The Economic Effects of Trade Policy Uncertainty, 109 J. Monetary Econ. 38 (2020), available at https://www.federalreserve.gov/econres/ifdp/files/ifdp1256.pdf; see also Kyle Handley & Nuno Limão, Trade Policy Uncertainty, 14 Ann. Rev. Econ. 363 (2022), available at https://www.nber.org/papers/w29672.
[14] Id.
[15] Richard Bartlett et al., Medtech Pulse: Thriving in the Next Decade, McKinsey & Co. (Sep. 2023), available at https://www.mckinsey.com/~/media/mckinsey/industries/life%20sciences/our%20insights/medtech%20pulse%20thriving%20in%20the%20next%20decade/medtech-pulse-thriving-in-the-next-decade.pdf; Innovation — The European Medical Technology in Figures, MedTech Europe, https://www.medtecheurope.org/datahub/innovation (last visited Oct. 15, 2025).
[16] Section 232 Investigations: Overview and Issues for Congress, Cong. Res. Svc. (2021), available at https://www.congress.gov/crs_external_products/R/PDF/R45249/R45249.35.pdf; Scott Lincicome & Inu Manak, Protectionism or National Security? The Use and Abuse of Section 232, Policy Analysis No. 912, Cato Inst. (2021), https://www.cato.org/policy-analysis/protectionism-or-national-security-use-abuse-section-232.
[17] 19 U.S.C. § 1862; see also Section 232 Investigations Program, U.S. Dep’t of Commerce Bure. of Ind. & Sec., https://www.bis.doc.gov/232 (last visited Oct. 15, 2025).
[18] Id.
[19] 21 C.F.R. § 820 (2025).
[20] See Ben Bancroft, Ultimate Guide to Supplier Management for Medical Device Companies, Greenlight Guru (Nov. 8, 2023), https://www.greenlight.guru/blog/supplier-management-medical-device; Medical Device Supplier Management: Definition, Requirements, and Process, SimplerQMS (Aug. 11, 2025), https://simplerqms.com/medical-device-supplier-management; Quality System Regulation: Process Validation, U.S. Food & Drug Admin. (2015), available at https://www.fda.gov/media/94074/download.
[21] See Medical Technologies, U.S. Int’l Trade Admin., https://www.trade.gov/medical-technologies-0 (last visited Oct. 15, 2025); see also Medical Device Industry Facts, AdvaMed, https://www.advamed.org/medical-device-industry-facts (last visited Oct. 15, 2025).
[22] Facts & Figures 2024, MedTech Europe (Jul. 2024), available at https://www.medtecheurope.org/wp-content/uploads/2024/07/medtech-europe–facts-figures-2024.pdf.
[23] See, e.g., Scott Whitaker, Testimony Before the U.S. Senate Committee on Finance, AdvaMed (May 14, 2025), at 1, https://www.advamed.org/industry-updates/news/advamed-testifies-in-u-s-senate.
[24] SelectUSA: Medical Technology Industry, U.S. Int’l Trade Admin., https://www.trade.gov/selectusa-medical-technology-industry (last visited Oct. 15, 2025).
[25] Id.
[26] Medical Devices and Equipment: Competitive Conditions, U.S. Int’l Trade Comm’n (2006), at 4, available at https://www.usitc.gov/publications/332/pub3909.pdf.
[27] U.S. Medical Devices: Imports and Exports, the Role of Tariffs and the FDA, Fla. Int’l. Med. Expo (2020), available at https://www.fimeshow.com/content/dam/Informa/fimeshow/en/downloads/FIME20-US-medical-device-report-eng.pdf.
[28] Healthcare Resource Guide – European Union, U.S. Int’l Trade Admin., https://www.trade.gov/healthcare-resource-guide-european-union; Brian Daigle & Mihir Torsekar, The EU Medical Device Regulation and the U.S. Medical Device Industry, J. Int’l Commerce & Econ. (Nov. 2019), available at https://www.usitc.gov/publications/332/journals/eu_medical_device_regulation_us_medical_device_industry.pdf.
[29] Instruments and Appliances Used in Medical or Veterinary Sciences: 2023 Imports by Country (HS 901890), World Bank, https://wits.worldbank.org/trade/comtrade/en/country/ALL/year/2023/tradeflow/Imports/partner/WLD/product/901890 (last visited Oct. 15, 2025).
[30] Country Commercial Guide: Canada — Medical Devices, U.S. Int’l Trade Admin., https://www.trade.gov/country-commercial-guides/canada-medical-devices (last visited Oct. 15, 2025).
[31] See FIME, supra note 28.
[32] See Hessam Mehrabi & Rambod Behboodi, The Evolving Tariff Threat: Impact on Med-Tech and Life Science Industries, Borden Ladner Gervais LLP (Feb. 27, 2025), https://www.blg.com/en/insights/2025/02/the-evolving-tariff-threat-impact-on-med-tech-and-life-science-industries.
[33] See Medical Devices: Industry Profile, Innov., Sci. & Econ. Dev. Can., https://ised-isde.canada.ca/site/canadian-life-science-industries/en/medical-devices/industry-profile (last visited Oct. 15, 2025).
[34] See Country Commercial Guide: South Korea — Medical Equipment and Devices, U.S. Int’l Trade Admin., https://www.trade.gov/country-commercial-guides/south-korea-medical-equipment-and-devices (last visited Oct. 15, 2025).
[35] See CGlobalization of U.S. Medical Product Supply Chains, in Medical Product Access and Innovation, Nat’l Acads. Press (2021), https://www.ncbi.nlm.nih.gov/books/NBK583730.
[36] COVID-19 Ventilator Shortage: Manufacturing Solution, World Econ. Forum (2020), https://www.weforum.org/stories/2020/04/covid-19-ventilator-shortage-manufacturing-solution.
[37] Ventilator Manufacturer Ramps Up Production Amid Coronavirus Crisis, 24×7Mag (Mar. 22, 2020), https://24x7mag.com/medical-equipment/patient-care-equipment/ventilators/ventilator-manufacturer-ramps-production-coronavirus-crisis.
[38] One Crisis, Different Paths to Supply Resilience, Nat’l Lib. of Med. (2022), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9705261.
[39] Samuel M. Goodman, COVID-19 Testing Supplies One Year into the Pandemic (USITC Working Paper ID-21-076, 2021), available at https://www.usitc.gov/publications/332/working_papers/wp_id_21_076_covid-19_testing_supplies_compiled_052121-compliant.pdf.
[40] Richard Baldwin & Rebecca Freeman, Risks and Global Supply Chains: What We Know and What We Need to Know (NBER Working Paper No. 29444, 2021), available at https://www.nber.org/system/files/working_papers/w29444/w29444.pdf.
[41] Susan Lund, Building National Supply Chain Resilience, McKinsey Glob. Inst. (Jul. 11, 2021), https://www.mckinsey.com/mgi/media-center/building-national-supply-chain-resilience.
[42] See The 2024 Global Medtech Contract Manufacturing Report, Alira Health (Feb. 2024), available at https://alirahealth.com/wp-content/uploads/The-2024-Global-Medtech-Contract-Manufacturing-Report.pdf.
[43] See Medtech CDMOs in Southeast Asia: Landscape Overview and Investment Opportunities, L.E.K. Consult. (Jun. 17, 2025), available at https://www.lek.com/sites/default/files/insights/pdf-attachments/medtech-cdmos-sea.pdf; What Makes Singapore the Best Hub in Asia for MedTech Manufacturing, Sing. Econ. Dev. Bd. (Nov. 11, 2024), https://www.edb.gov.sg/en/business-insights/insights/what-makes-singapore-the-best-hub-in-asia-for-medtech-manufacturing.html.
[44] See Decoding Tariff Volatility: How MedTech Must Remodel for Resilience, Kearney (Jul. 30. 2025), https://www.kearney.com/industry/health/article/decoding-tariff-volatility-how-medtech-must-remodel-for-resilience.
[45] See MDSAP: Purpose, Structure & Participating Authorities, Med. Dev. Sngl. Audit Program, https://www.mdsap.global (last visited Oct. 15, 2025).
[46] Principles and Practices for Medical Device Cybersecurity, Int’l. Med. Dev. Regulators Forum (Mar. 18, 2020), available at https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-pp-mdc-n60.pdf.
[47] Securing Medical Supply Chains in a Post-Pandemic World, OECD (2024), https://www.oecd.org/en/publications/2024/02/securing-medical-supply-chains-in-a-post-pandemic-world_3c8cef7c.html.
[48] See, e.g., Laura Lebastard, Marco Matani, & Roberta Serafini, Understanding the Impact of COVID-19 Supply Disruptions on Exporters in Global Value Chains, CEPR/VoxEU (Mar. 24, 2023), https://cepr.org/voxeu/columns/understanding-impact-covid-19-supply-disruptions-exporters-global-value-chains.
[49] Id.
[50] Building Supply Chain Resilience: White Paper, AdvaMed (2023), available at https://www.advamed.org/wp-content/uploads/2023/06/Building-Supply-Chain-Resilience-White-Paper-final.pdf.
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Scholarship (Affiliate)ICLE Comments on Section 232 Investigation into PPE, Medical Consumables, and Medical Equipment
I. Introduction
The International Center for Law & Economics (ICLE) appreciates this opportunity to comment on the Bureau of Industry and Security’s investigation of the national-security implications of imports of personal protective equipment (PPE), medical consumables, and medical equipment. ICLE is a nonprofit research center that applies economic analysis to questions of law and regulation.
We oppose the application of Section 232 tariffs to medical devices and related products. The United States leads the world in medical-technology innovation and manufacturing, supported by open, rules-based trade with trusted allies. Imports of devices and components complement, rather than displace, U.S. production. Moreover, they are essential to maintain an efficient, resilient, and globally competitive health-care system.
Tariffs would raise costs for hospitals and patients, suppress investment and R&D, and undermine the very innovation that underpins U.S. health-security preparedness. Consistent with Section 232’s statutory purpose, U.S. policy should reinforce the strength of allied supply chains and maintain predictable, cooperative trade relationships that support—not impair—the nation’s medical-technology base.
II. Economic and Public-Health Impacts of Tariffs
Open and competitive trade is the foundation of economic prosperity, especially in innovation-driven sectors like medical technology. When markets are open, firms face competitive pressure to become more efficient, adopt new technologies, and invest in R&D. A broad literature confirms that exposure to global markets drives productivity growth, facilitates technology transfer, and supports sustained U.S. global leadership: the United States controls roughly 40% of the medical-technology (“medtech”) market, while export volumes exceed $141 billion and industry reinvestment in product innovation remains high.[1]
The proposed application of Section 232 tariffs would reverse this dynamic, imposing new costs and instability throughout the medical-technology ecosystem. Modern trade theory emphasizes that comparative advantage evolves dynamically.[2] Access to international markets reshapes domestic capabilities by rewarding sectors that innovate and scale globally. This dynamic interplay between openness and innovation explains why U.S. medtech firms dominate such advanced product segments as imaging, diagnostics, and surgical robotics.
Conversely, barriers like tariffs or quotas impede this evolution, isolating firms from global knowledge flows and eroding long-term competitiveness. Maintaining open, rules-based trade with trusted partners thus strengthens—not threatens—U.S. economic security by reinforcing innovation, efficiency, and resilience in critical health-related industries.
Moreover, imposing tariffs on imports of medical devices, consumables, or related components under Section 232 would increase costs throughout the U.S. health-care system, slow adoption of advanced technologies, and weaken—rather than strengthen—national resilience. Because U.S. health providers operate under fixed reimbursement schedules, any increase in device costs directly translates into higher expenditures for hospitals, insurers, and Medicare, ultimately reducing patient access to life-saving technologies.
A. Tariffs Would Raise Input Costs for Hospitals and Health Systems
Hospitals and health systems already face persistent financial pressure due to inflation, labor shortages, and static Medicare-reimbursement rates. Tariffs would compound these pressures by increasing the cost of imported components and finished products that are integral to medical care. A 2024 analysis found that 82% of health-system executives expected tariff-related import expenses to raise hospital costs by about 15% within six months.[3] Likewise, tariffs on critical supplies are expected to increase costs and reduce availability of key products for hospitals.[4] These higher input prices are not absorbed by manufacturers alone; they are passed through the supply chain and ultimately borne by hospitals, private insurers, and federal programs like Medicare and Medicaid.
During prior rounds of Section 301 tariffs on Chinese medical imports, manufacturers and distributors in the medical-device sector reported cost pressures on various device components and subassemblies—such as electronics, sensors, housings, and tubing—especially for diagnostic, monitoring, and surgical devices.[5] This experience illustrates that trade restrictions intended to promote domestic production often have the opposite effect in highly integrated industries—eroding competitiveness and diminishing capacity for innovation.
B. Tariffs Would Raise Consumer Prices and Delay Adoption of Advanced Medical Technologies
Medical devices are capital-intensive goods with long procurement cycles and complex regulatory-approval requirements. When hospitals anticipate higher import prices or uncertain supply, they may postpone or cancel equipment upgrades. Tariffs on medical products would likely further strain an already fragile health-care supply chain, driving up costs and reducing the availability of essential medical devices and equipment.[6] Similarly, medtech manufacturers anticipate a combined tariff impact of more than $2 billion across 2024-2025, forcing many firms to reduce production and defer new-product launches.[7] As device upgrades are delayed, hospitals must continue using older, less-efficient technologies—directly undermining the goal of a modern and resilient health-care infrastructure.
Moreover, while a few multinational firms maintain relatively high returns, the medical-device sector actually operates on narrow effective margins, once research, compliance, and capital costs are included. Large device companies typically have profit margins of 20-30%.[8] Yet industry data suggest that the medical equipment and supplies sector on the whole now reports net margins in the upper single digits, with operating margins near 10%.[9] Recent financial benchmarking indicates that smaller and mid-sized medical-device manufacturers—firms responsible for much of the industry’s innovation—operate with earnings before interest and taxes (EBIT) of roughly 4.6% of their revenues, reflecting the sector’s tight margins relative to larger diversified medtech companies.[10] When margins are this thin, tariff costs cannot be easily absorbed; they are inevitably passed through, in large part, to hospitals and consumers in the form of higher prices.
Reduced profitability and policy uncertainty also discourage R&D investment. Industry analysis illustrates that medtech profitability has declined globally in recent years, with average operating income falling by roughly three percentage points, as inflation, supply-chain disruptions, and regulatory costs have all increased.[11] Additional tariff-driven cost increases would intensify this compression, leaving fewer resources for R&D and compliance.
And while medtech firms often enjoy healthy gross margins, those margins are critical to funding ongoing innovation. When those margins erode, firms lose the flexibility to reinvest in R&D, slowing the pace of new-product development.[12] Tariffs will shrink both the gross margins and the net margins, driving further retrenchment and depressing institutional capacity to invest in R&D.
The combined effect of higher import prices, reduced investment, and delayed innovation would therefore be fewer new medical technologies entering the U.S. market and slower replacement of aging equipment. In the long term, these consequences would erode the resilience of the U.S. health-care system—the very objective that these Section 232 investigations seek to secure.
C. Trade-Policy Uncertainty and Investment in Medical Technology
Even before tariffs take effect, the uncertainty surrounding their potential imposition can suppress investment and innovation in the medical-technology sector. Economists have long observed that volatility in trade policy leads firms to postpone or cancel capital expenditures and R&D, a dynamic known as the “real options” effect. When future input costs or market-access rules are unclear, it becomes rational for companies to delay irreversible investments until policy direction stabilizes. The cumulative effect across the industry is lower aggregate investment, slower entry into new markets, and diminished innovation.[13]
Empirical studies of the 2018–2019 trade-tension period found that a one-standard-deviation rise in trade-policy uncertainty reduced U.S. manufacturing investment by roughly 1–2% over the following year, independent of what actual tariff levels were imposed.[14] For innovation-intensive industries like medtech—where R&D costs typically take up 8% of annual revenues[15]—policy instability can translate quickly into deferred product development and delayed regulatory submissions. Firms facing uncertainty about tariff coverage, reimbursement effects, or retaliatory measures have strong incentives to redirect resources toward short-term operations, rather than long-term innovation.
Stable and predictable trade rules therefore constitute a precondition for maintaining U.S. technological leadership in medical devices. A tariff-driven environment characterized by periodic investigations and changing duty rates not only raises costs directly, but also magnifies uncertainty, depressing forward-looking investment across the supply chain. In this sense, trade-policy volatility functions as a hidden tax on innovation. A consistent, rules-based approach to international medical-device trade, anchored in transparency and allied cooperation, would better support the long-term competitiveness and national-security resilience of the U.S. medtech industry.
D. Tariffs on PPE Are an Inappropriate Economic Tool to Promote Reshoring
Importantly, Section 232 authority was designed to address genuine national-security threats from adversarial sources, not to penalize allied trade. Historically, successful 232 actions have targeted steel, aluminum, or critical minerals dominated by non-allied producers.[16] Applying this national-security tool to medical devices imported chiefly from NATO and USMCA partners would be inconsistent with both statutory intent and economic logic.[17] As the Bureau of Industry and Security has noted, the statute’s purpose is to mitigate “whether the importation of the article in question is in such quantities or under such circumstances as to threaten to impair the national security,” not to disrupt allied cooperation essential to public health.[18]
Further, medical-device manufacturing is inherently capital intensive and heavily regulated by the U.S. Food and Drugs Administration (FDA). Under 21 C.F.R. Part 820, manufacturers must validate every production line and supplier, with significant documentation and preapproval requirements for any process change.[19]
Although a tariff shock might be intended to spur reshoring, firms must in practice incur significant sunk costs and time to requalify suppliers and production processes. In the medical-device sector, supplier requalification itself often takes months, and includes mandatory audits, capability studies, quality-agreement updates, and validation under regulatory frameworks like 21 C.F.R. § 820.[20] Because many changes may require full validation of process and materials, the short-term shift in capacity is highly constrained and may lead to disruptions or shortages before any new domestic capacity becomes viable.
In short, Section 232 tariffs on medical devices and PPE would misidentify the source of risk. They would penalize integrated trade with close allies, undermine established regulatory and manufacturing networks, and inflict economic harm on precisely the industries that anchor U.S. health-security resilience.
III. The U.S. Medical Technology Industry: A Global Leader
Given the foregoing description of the economics of the medtech industry, it is worth asking why this sector—long a cornerstone of U.S. innovation and export strength—should be viewed as a national-security vulnerability at all. The United States is the undisputed global leader in medical-technology innovation and manufacturing. Indeed, U.S. companies account for roughly 40% of worldwide medical-device production, by far the largest share of any country.[21]
The medtech sector is defined by high-value, research-intensive manufacturing. The industry consistently reinvests around 7–8% of revenues into R&D, ranking among the highest R&D intensities in manufacturing.[22] This robust innovation ecosystem—fueled by leading research universities, deep venture-capital markets, and strong intellectual-property protections—drives continual advances in imaging equipment, in-vitro diagnostics, surgical robotics, and implantable devices. For example, U.S. firms are at the forefront of MRI and CT imaging technology, next-generation glucose monitors and diagnostic assays, robotic-assisted surgical systems, and artificial joints and stents, among many other cutting-edge products.[23]
The industry’s emphasis on innovation not only saves lives but also supports a high-skill domestic workforce: approximately 500,000 workers are employed directly in the U.S. medical-device-manufacturing industry, with total direct and indirect employment approaching 2 million.[24]
U.S. medtech firms are also vigorous exporters. The United States exported more than $100 billion in medical devices and related equipment in 2023.[25] Even in key product categories where global competition is intense, American firms excel. In earlier years, the United States achieved net export surpluses in high-value device categories such as diagnostic imaging and orthopedics. [26] Although more recent trade data show changes in the balance, the United States remains a leading global exporter in those segments.[27] These high-end devices—often produced by U.S. companies at home or in close trade-partner countries—compete on quality and innovation, rather than low cost.
In sum, the U.S. medtech industry’s global leadership is built on innovation, skilled employment, and export success. These factors underscore that America’s medical-device-manufacturing base is strong and globally competitive, a foundation for national health security that open trade further reinforces.
A. Allied Trade Relationships and Balanced Flows
The U.S. medical technology industry is deeply integrated into reciprocal trade relationships with allied economies, resulting in balanced flows of devices and components. America’s major trading partners for medical devices are not adversaries, but close allies: Europe (especially Germany, Ireland, and the Netherlands), Canada, Mexico, Japan, South Korea, and Singapore are both among the top sources of U.S. medtech imports and major destinations for U.S. exports.
In 2018, for example, the United States exported more than $20 billion in medical devices to the EU, which has historically accounted for nearly 40% of U.S. device exports.[28] Import data show that the European Union is also an important supplier of U.S. medical instruments. In 2023, it contributed roughly $11.5 billion of $19.5 billion in U.S. imports in that device category (roughly 59%).[29]
Meanwhile, North American partners—especially Canada and Mexico—play significant roles as regional suppliers and exporters in complementary device segments.[30] U.S.–Mexico trade in medical devices is largely balanced and complementary. In recent years, Mexico has been the leading supplier of U.S. medical-device imports, accounting for roughly 17% of total import value—mainly lower-technology products such as disposables and surgical instruments produced through cross-border manufacturing.[31]
Canada is also both a significant market and supplier in U.S. medical-device trade. Exports of medical equipment, supplies, and control instruments from Canada to the United States exceeded $6.8 billion in 2024.[32] Meanwhile, in 2024, Canada’s medical-device imports from the United States were C$5.9 billion, representing about 42% of Canada’s total medtech imports.[33]
In Asia, Japan and South Korea both purchase high-value U.S. devices (for example, Japanese hospitals import American orthopedic implants and diagnostic instruments), even as companies in those countries supply the United States with specialized components like optical lenses and semiconductor parts for medical equipment.[34]
These trade relationships are characterized by a two-way flow of goods: U.S. companies export complex finished devices and receive in return a range of inputs, subassemblies, and some finished products from allied nations. Importantly, imports from China constitute only a relatively small fraction of U.S. medtech imports (roughly 10% in recent years) and that share has been declining as U.S. sourcing diversifies toward allied suppliers.[35]
The evidence suggests a supply-chain strategy centered on trusted partners. The reciprocity and balance in these trade flows demonstrate that imports are largely coming from friends, and U.S. firms are succeeding in selling globally. Far from one-sided dependence, U.S. medtech trade with allies strengthens all parties.
B. Imports’ Role in Meeting U.S. Health-Care Demand
The COVID-19 pandemic offered a stark illustration of the importance of global supply networks in meeting surges in health-care demand. In normal times, imports fill critical gaps in the U.S. health system’s needs for medical devices and supplies, especially for specialized or lower-volume products that are not efficient to manufacture domestically at scale.
During the height of the pandemic, the United States leveraged imports from allies to rapidly scale up life-saving equipment. A prominent example was the surge in ventilator production in 2020: even as American manufacturers like General Motors and ventilator companies retooled to assemble ventilators domestically, they depended on imported inputs (valves, sensors, oxygen concentrators, etc.) from partner countries to boost output. According to contemporary analyses, the only feasible way to meet the unprecedented 500–1,000% increase in ventilator demand was to “supercharge ventilator makers’ global production capacities” by pooling resources across borders, rather than attempting total self-reliance.[36]
For example, Medtronic’s Ireland-based ventilator manufacturing facility reportedly ramped up production, reallocating staff and expanding shift coverage to supply global demand.[37] More broadly, European manufacturers took coordinated steps to bolster ventilator-component supply chains across countries.[38] Similarly, COVID-19 diagnostic test kits were produced through transnational cooperation, with U.S. labs relying on reagents and chemicals from allies (and vice versa) to scale up testing quickly.[39]
In short, imports function as both a safety valve and a source of resilience for U.S. health care; they ensure that American patients and doctors have timely access to every medical tool needed, especially when domestic production alone cannot immediately meet a spike in demand.
C. Resilience Through Diversification, Not Isolation
Policymakers increasingly recognize that supply-chain resilience in medical technology comes from diversification across trusted partners, rather than from attempting an autarkic approach. Empirical research on the recent supply disruptions demonstrates that geographic concentration of production is the primary vulnerability—for instance, overreliance on a single country or region for a critical component can create a choke point—whereas maintaining “safe openness” through a broad network of suppliers reduces risk.[40] Resilient medical supply chains depend on broad, cross-border diversification with built-in redundancies that allow production to adjust rapidly in response to shocks or disruptions.[41] In the medical-device sector, both industry and government have moved to implement this lesson.
U.S. and European manufacturers are increasingly coordinating to establish redundant production capacity for critical products. For example, U.S. medtech OEMs maintain production sites abroad to enable geographic flexibility in manufacturing.[42] Some have explicitly expanded manufacturing operations in Singapore and Southeast Asia, enabling them to shift production among locations in response to demand or disruption.[43] Major medtech firms from the United States, EU, and Japan also frequently rely on one another’s components, creating inherent redundancies—if one source goes offline, alternative sources in another allied nation can fill the gap.[44]
Such collaborative redundancy is bolstered by reciprocal regulatory recognition initiatives among allies. A salient case is the Medical Device Single Audit Program (MDSAP), which pledges the FDA and regulators in Canada, Japan, Australia, and other jurisdictions to accept a single standardized quality audit of a device manufacturer.[45] Programs like MDSAP streamline compliance across countries, enabling companies to shift production or substitute suppliers rapidly across jurisdictions without regulatory delay. Likewise, international regulatory guidance—such as the International Medical Device Regulators Forum’s (IMDRF) medical-device cybersecurity framework—explicitly aims for convergence of cybersecurity principles and practices across jurisdictions to preserve device functionality and patient safety, thereby enabling mutual reliance on allied medical products in emergencies.[46]
Crucially, embracing imports from a diverse set of allied economies enhances U.S. preparedness. A strong consensus has emerged that attempting to localize entire supply chains domestically would undermine resilience by cutting off access to alternative sources. A 2024 OECD report, for example, found that shortages in critical medical goods were best addressed by maintaining multiple sourcing options across different countries—smoothing potential disruptions.[47] Diversified global supply networks tend to recover faster from shocks than isolated national chains.[48] Similarly, countries with more trade partners had fewer medical supply shortages during COVID-19, whereas those dependent on one foreign source or solely on domestic production faced greater scarcity.[49]
The medtech sector’s own experience confirms that open, allied trade is a strength. The U.S. medical technology base is robust, in large part, due to its global links. Diversified sourcing enables “a consistent response to external stressors” and prevents overreliance on any single market or supplier.[50] In short, maintaining and expanding imports from trusted allies is not a strategic liability but a strategic asset for the United States. It builds redundancy, ensures access to lifesaving technologies not made at home, and grants flexibility to manage crises. In the face of pandemics and other disruptions, a diverse allied supply chain is America’s first line of defense, whereas protectionism and concentration would only foment greater fragility.
IV. Conclusion
The U.S. medtech sector is a pillar of both economic strength and national health security. Its global leadership depends on openness, stability, and collaboration with trusted trade partners. Section 232 tariffs on medical devices or PPE would erode these advantages—raising costs, amplifying uncertainty, and diverting resources away from the research and innovation that safeguard public health.
Rather than broad trade restrictions, national-security policy should focus on targeted, evidence-based measures that address specific vulnerabilities, while preserving the benefits of allied integration. A predictable, rules-based trade environment is essential to maintain U.S. competitiveness, investment, and readiness in critical medical technologies.
Accordingly, ICLE urges the U.S. Commerce Department to reject the use of Section 232 tariffs in this proceeding and to reaffirm that open, cooperative trade among allies is an asset to U.S. security—not a threat to it.
[1] See Medical Technology Industry, U.S. Int’l Trade Admin. SelectUSA, https://www.trade.gov/selectusa-medical-technology-industry (last visited Oct. 15, 2025); see also Medical Technologies, U.S. Int’l Trade Admin., https://www.trade.gov/medical-technologies-0 (last visited Oct. 15, 2025).
[2] See infra Section III.
[3] Sunit Patel & Rupert Watson, The Impact of Tariffs on Healthcare Costs, Mercer (Apr. 10, 2025), https://www.mercer.com/en-us/insights/us-health-news/the-impact-of-tariffs-on-healthcare-costs.
[4] Tina Freese Decker, Tariff Implications for American Health Care, AHA News (May 19, 2025), https://www.aha.org/news/chairpersons-file/2025-05-19-tariff-implications-american-health-care.
[5] See, e.g., Analysis of Section 301 Tariff Impacts on Electromedical Devices, Wash. Int’l Trade Ass’n (2022), available at https://www.wita.org/wp-content/uploads/2022/08/CTA_Section-301-Tariff-Whitepaper.pdf; see also The Hidden Risks of Tariffs in Medical Device Supply Chains, Everstream Anal., https://www.everstream.ai/articles/hidden-risk-tariffs-medical-devices (last visited Oct. 16, 2025).
[6] Robert M. Orfaly, Tariffs May Strain the Fragile Healthcare Supply Chain, AAOS Now (May 29, 2025), https://www.aaos.org/aaosnow/2025/may/commentary/commentary01.
[7] Susan Kelly, Cost Cuts, Production Shifts: How MedTech Firms Are Managing Tariffs, MedTech Dive (May 22, 2025), https://www.medtechdive.com/news/medtech-Q1-earnings-tariffs-impact/748794.
[8] An Overview of the Medical Device Industry (Ch. 7), in Report to the Congress: Medicare and the Health Care Delivery System, Medicare Payment Advis. Comm’n (Jun. 2017), available at https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/reports/jun17_ch7.pdf.
[9] Medical Equipment & Supplies Industry Profitability Ratios, CSIMarket, https://csimarket.com/Industry/industry_Profitability_Ratios.php?ind=804 (last visited Oct. 15, 2025).
[10] Medical Device Manufacturing: Industry M&A Trends, Valuation, and Financial Performance, InvestmentBank.com (Jun. 22, 2025), https://investmentbank.com/insights/medical-device-industry.
[11] Global MedTech 2023 – Stem the Tide, Roland Berger (2023), available at https://content.rolandberger.com/hubfs/07_presse/Global_MedTech_2023.pdf.
[12] See id.; See also Pulse of the MedTech Industry Report 2025, EY Insights (2025), available at https://www.ey.com/content/dam/ey-unified-site/ey-com/en-gl/industries/life-sciences/documents/ey-gl-medtech-pulse-report-09-2025.pdf.
[13] See, generally, Dario Caldara et al., The Economic Effects of Trade Policy Uncertainty, 109 J. Monetary Econ. 38 (2020), available at https://www.federalreserve.gov/econres/ifdp/files/ifdp1256.pdf; see also Kyle Handley & Nuno Limão, Trade Policy Uncertainty, 14 Ann. Rev. Econ. 363 (2022), available at https://www.nber.org/papers/w29672.
[14] Id.
[15] Richard Bartlett et al., Medtech Pulse: Thriving in the Next Decade, McKinsey & Co. (Sep. 2023), available at https://www.mckinsey.com/~/media/mckinsey/industries/life%20sciences/our%20insights/medtech%20pulse%20thriving%20in%20the%20next%20decade/medtech-pulse-thriving-in-the-next-decade.pdf; Innovation — The European Medical Technology in Figures, MedTech Europe, https://www.medtecheurope.org/datahub/innovation (last visited Oct. 15, 2025).
[16] Section 232 Investigations: Overview and Issues for Congress, Cong. Res. Svc. (2021), available at https://www.congress.gov/crs_external_products/R/PDF/R45249/R45249.35.pdf; Scott Lincicome & Inu Manak, Protectionism or National Security? The Use and Abuse of Section 232, Policy Analysis No. 912, Cato Inst. (2021), https://www.cato.org/policy-analysis/protectionism-or-national-security-use-abuse-section-232.
[17] 19 U.S.C. § 1862; see also Section 232 Investigations Program, U.S. Dep’t of Commerce Bure. of Ind. & Sec., https://www.bis.doc.gov/232 (last visited Oct. 15, 2025).
[18] Id.
[19] 21 C.F.R. § 820 (2025).
[20] See Ben Bancroft, Ultimate Guide to Supplier Management for Medical Device Companies, Greenlight Guru (Nov. 8, 2023), https://www.greenlight.guru/blog/supplier-management-medical-device; Medical Device Supplier Management: Definition, Requirements, and Process, SimplerQMS (Aug. 11, 2025), https://simplerqms.com/medical-device-supplier-management; Quality System Regulation: Process Validation, U.S. Food & Drug Admin. (2015), available at https://www.fda.gov/media/94074/download.
[21] See Medical Technologies, U.S. Int’l Trade Admin., https://www.trade.gov/medical-technologies-0 (last visited Oct. 15, 2025); see also Medical Device Industry Facts, AdvaMed, https://www.advamed.org/medical-device-industry-facts (last visited Oct. 15, 2025).
[22] Facts & Figures 2024, MedTech Europe (Jul. 2024), available at https://www.medtecheurope.org/wp-content/uploads/2024/07/medtech-europe–facts-figures-2024.pdf.
[23] See, e.g., Scott Whitaker, Testimony Before the U.S. Senate Committee on Finance, AdvaMed (May 14, 2025), at 1, https://www.advamed.org/industry-updates/news/advamed-testifies-in-u-s-senate.
[24] SelectUSA: Medical Technology Industry, U.S. Int’l Trade Admin., https://www.trade.gov/selectusa-medical-technology-industry (last visited Oct. 15, 2025).
[25] Id.
[26] Medical Devices and Equipment: Competitive Conditions, U.S. Int’l Trade Comm’n (2006), at 4, available at https://www.usitc.gov/publications/332/pub3909.pdf.
[27] U.S. Medical Devices: Imports and Exports, the Role of Tariffs and the FDA, Fla. Int’l. Med. Expo (2020), available at https://www.fimeshow.com/content/dam/Informa/fimeshow/en/downloads/FIME20-US-medical-device-report-eng.pdf.
[28] Healthcare Resource Guide – European Union, U.S. Int’l Trade Admin., https://www.trade.gov/healthcare-resource-guide-european-union; Brian Daigle & Mihir Torsekar, The EU Medical Device Regulation and the U.S. Medical Device Industry, J. Int’l Commerce & Econ. (Nov. 2019), available at https://www.usitc.gov/publications/332/journals/eu_medical_device_regulation_us_medical_device_industry.pdf.
[29] Instruments and Appliances Used in Medical or Veterinary Sciences: 2023 Imports by Country (HS 901890), World Bank, https://wits.worldbank.org/trade/comtrade/en/country/ALL/year/2023/tradeflow/Imports/partner/WLD/product/901890 (last visited Oct. 15, 2025).
[30] Country Commercial Guide: Canada — Medical Devices, U.S. Int’l Trade Admin., https://www.trade.gov/country-commercial-guides/canada-medical-devices (last visited Oct. 15, 2025).
[31] See FIME, supra note 28.
[32] See Hessam Mehrabi & Rambod Behboodi, The Evolving Tariff Threat: Impact on Med-Tech and Life Science Industries, Borden Ladner Gervais LLP (Feb. 27, 2025), https://www.blg.com/en/insights/2025/02/the-evolving-tariff-threat-impact-on-med-tech-and-life-science-industries.
[33] See Medical Devices: Industry Profile, Innov., Sci. & Econ. Dev. Can., https://ised-isde.canada.ca/site/canadian-life-science-industries/en/medical-devices/industry-profile (last visited Oct. 15, 2025).
[34] See Country Commercial Guide: South Korea — Medical Equipment and Devices, U.S. Int’l Trade Admin., https://www.trade.gov/country-commercial-guides/south-korea-medical-equipment-and-devices (last visited Oct. 15, 2025).
[35] See CGlobalization of U.S. Medical Product Supply Chains, in Medical Product Access and Innovation, Nat’l Acads. Press (2021), https://www.ncbi.nlm.nih.gov/books/NBK583730.
[36] COVID-19 Ventilator Shortage: Manufacturing Solution, World Econ. Forum (2020), https://www.weforum.org/stories/2020/04/covid-19-ventilator-shortage-manufacturing-solution.
[37] Ventilator Manufacturer Ramps Up Production Amid Coronavirus Crisis, 24×7Mag (Mar. 22, 2020), https://24x7mag.com/medical-equipment/patient-care-equipment/ventilators/ventilator-manufacturer-ramps-production-coronavirus-crisis.
[38] One Crisis, Different Paths to Supply Resilience, Nat’l Lib. of Med. (2022), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9705261.
[39] Samuel M. Goodman, COVID-19 Testing Supplies One Year into the Pandemic (USITC Working Paper ID-21-076, 2021), available at https://www.usitc.gov/publications/332/working_papers/wp_id_21_076_covid-19_testing_supplies_compiled_052121-compliant.pdf.
[40] Richard Baldwin & Rebecca Freeman, Risks and Global Supply Chains: What We Know and What We Need to Know (NBER Working Paper No. 29444, 2021), available at https://www.nber.org/system/files/working_papers/w29444/w29444.pdf.
[41] Susan Lund, Building National Supply Chain Resilience, McKinsey Glob. Inst. (Jul. 11, 2021), https://www.mckinsey.com/mgi/media-center/building-national-supply-chain-resilience.
[42] See The 2024 Global Medtech Contract Manufacturing Report, Alira Health (Feb. 2024), available at https://alirahealth.com/wp-content/uploads/The-2024-Global-Medtech-Contract-Manufacturing-Report.pdf.
[43] See Medtech CDMOs in Southeast Asia: Landscape Overview and Investment Opportunities, L.E.K. Consult. (Jun. 17, 2025), available at https://www.lek.com/sites/default/files/insights/pdf-attachments/medtech-cdmos-sea.pdf; What Makes Singapore the Best Hub in Asia for MedTech Manufacturing, Sing. Econ. Dev. Bd. (Nov. 11, 2024), https://www.edb.gov.sg/en/business-insights/insights/what-makes-singapore-the-best-hub-in-asia-for-medtech-manufacturing.html.
[44] See Decoding Tariff Volatility: How MedTech Must Remodel for Resilience, Kearney (Jul. 30. 2025), https://www.kearney.com/industry/health/article/decoding-tariff-volatility-how-medtech-must-remodel-for-resilience.
[45] See MDSAP: Purpose, Structure & Participating Authorities, Med. Dev. Sngl. Audit Program, https://www.mdsap.global (last visited Oct. 15, 2025).
[46] Principles and Practices for Medical Device Cybersecurity, Int’l. Med. Dev. Regulators Forum (Mar. 18, 2020), available at https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-pp-mdc-n60.pdf.
[47] Securing Medical Supply Chains in a Post-Pandemic World, OECD (2024), https://www.oecd.org/en/publications/2024/02/securing-medical-supply-chains-in-a-post-pandemic-world_3c8cef7c.html.
[48] See, e.g., Laura Lebastard, Marco Matani, & Roberta Serafini, Understanding the Impact of COVID-19 Supply Disruptions on Exporters in Global Value Chains, CEPR/VoxEU (Mar. 24, 2023), https://cepr.org/voxeu/columns/understanding-impact-covid-19-supply-disruptions-exporters-global-value-chains.
[49] Id.
[50] Building Supply Chain Resilience: White Paper, AdvaMed (2023), available at https://www.advamed.org/wp-content/uploads/2023/06/Building-Supply-Chain-Resilience-White-Paper-final.pdf.